A "Real World" Trial to Determine Efficacy and Health Outcomes of Toujeo (ACHIEVE CONTROL REAL LIFE STUDY PROGRAM)
- Conditions
- Diabetes Mellitus, Type 2
- Interventions
- Drug: Insulin glargine, 300 U/mlDrug: Insulin glargine, 100 U/mlDrug: Background Therapy
- Registration Number
- NCT02451137
- Lead Sponsor
- Sanofi
- Brief Summary
Primary Objective:
Demonstrate clinical benefit of Toujeo in achieving individualized Healthcare Effectiveness Data and Information Set (HEDIS) glycated hemoglobin (HbA1c) targets (\<8% if age \>=65 years or with defined comorbidities or otherwise \<7%) at 6 months without documented symptomatic (Blood Glucose \<=70 mg/deciliter \[mg/dL\]) and/or severe hypoglycemia at any time of day from baseline to 6 months in uncontrolled insulin naive participants with type 2 diabetes initiating basal insulin therapy in a real world setting.
Secondary Objectives:
Compare Toujeo to other commercially available basal insulins at 6 months after initiating insulin therapy in a real world setting in terms of:
* Participant persistence with assigned basal insulin therapy.
* Risk of hypoglycemia including the incidence and rate of documented symptomatic and severe hypoglycemia.
* Changes in HbA1c, fasting plasma glucose, body weight
* Differences in participant and provider- reported outcomes (including Diabetes Treatment Satisfaction Questionnaire Status and Change Versions (DTSQs) and (DTSQc), Hypoglycemia Patient Questionnaire, and participant and provider reported Global Effectiveness Scale (GES).
* Healthcare resource utilization including hospitalizations and emergency department or other provider visits and healthcare costs.
- Detailed Description
The total study duration per patient will be up to 53 weeks, consisting of a 1-week screening period at the site, a 26-week treatment period, and a 26-week extension period.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 3304
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Toujeo Background Therapy Toujeo® (Insulin glargine, 300 units per millilitre \[U/mL\]) subcutaneous (SC) injection once daily up to Month 12, with or without available participant support program. Toujeo Insulin glargine, 300 U/ml Toujeo® (Insulin glargine, 300 units per millilitre \[U/mL\]) subcutaneous (SC) injection once daily up to Month 12, with or without available participant support program. Standard of Care Insulin glargine, 100 U/ml Lantus® (Insulin glargine, 100 U/mL) SC injection administered once daily; or Levemir® (Insulin detemir) SC injection administered either once or twice daily up to Month 12, with or without available participant support program. Standard of Care Background Therapy Lantus® (Insulin glargine, 100 U/mL) SC injection administered once daily; or Levemir® (Insulin detemir) SC injection administered either once or twice daily up to Month 12, with or without available participant support program. Standard of Care Insulin detemir Lantus® (Insulin glargine, 100 U/mL) SC injection administered once daily; or Levemir® (Insulin detemir) SC injection administered either once or twice daily up to Month 12, with or without available participant support program.
- Primary Outcome Measures
Name Time Method Percentage of Participants With Individualized Glycated Hemoglobin Target Attainment Per Healthcare Effectiveness Data and Information Set (HEDIS) Criteria Without Documented Symptomatic(Blood Glucose <=70 mg/dL [<=3.9 mmol/L]) and/or Severe Hypoglycemia Baseline to Month 6 HEDIS criteria: Individualized HbA1c target \<8% if age \>= 65 years or presence of medical comorbidities, or otherwise \<7%. Severe hypoglycaemia was an event in which the participant required the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Documented symptomatic hypoglycaemia was an event during which typical symptoms of hypoglycaemia were accompanied by a measured plasma glucose concentration of \<=70 milligrams per deciliter (mg/dL) (\<=3.9 millimoles per litre \[mmol/L\]). Analysis was performed using all post-baseline data available on the 6 month randomized period (defined as time from randomization up to Day 180 or discontinuation date, whichever comes earlier).
- Secondary Outcome Measures
Name Time Method Change From Baseline in HbA1c at Month 6 and Month 12 Baseline, Month 6, Month 12 Change in HbA1c was calculated by subtracting baseline value from Month 6 and Month 12 values. Adjusted Least Squares (LS) means and Standard Errors (SE) were obtained using Mixed Effect Model with Repeated Measures (MMRM ) with fixed categorical effects of treatment arm, visit, treatment arm-by-visit interaction, randomization strata of HbA1c target (\<8% / \<7%), SU use (yes/no), GLP-1 RA use (yes/no), as well as baseline HbA1c (as continuous) and baseline HbA1c-by-visit interaction.
Treatment Persistence Measured by Medication Possession Ratio (MPR) At Month 6 and Month 12 Treatment persistence was determined based on vendor claims database that would be responsible for managing and administration of the study drugs. Medication use was assessed by MPR and persistence measures based on data collected by the smart card vendor (date of fill or refill and quantity of medication dispensed for 30-day supply). The MPR was assessed based on total number of days of supply divided by the total number of days in 6 or 12 months period.
Percentage of Participants Reaching Individualized HbA1c Target Without Documented Symptomatic <=3.9 mmol/L (<= 70 mg/dL) and <3.0 mmol/L (< 54 mg/dL) and/or Severe Hypoglycemia During the 12-Month Randomized Period Baseline to Month 12 HEDIS criteria for Individualized HbA1c target: \<8% if age \>= 65 years or presence of medical comorbidities, or otherwise \<7%. Severe hypoglycaemia was an event in which the participant required the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Documented symptomatic hypoglycaemia was an event during which typical symptoms of hypoglycaemia were accompanied by a measured plasma glucose concentration of \<=3.9 mmol/L (\<=70 mg/dL) and \< 3.0 mmol/L (\< 54 mg/dL).
Percentage of Responders (Participants and Provider) Who Reported "Excellent" or "Good" Responses to Global Effectiveness Scale (GES) Question at Month 6, and Month 12 At Month 6, Month 12 Participant and Physician (Provider) reported GES for this diabetes study. The GES assessed impact of treatment on scale ranges as: excellent (complete control of diabetes), good (marked improvement of diabetes), moderate (discernible, but limited improvement in diabetes), poor (no appreciable change in diabetes), or worsening of condition (worsening of diabetes). There was no score expressed by numbers and no change measured over the time of the study. Percentage of participants and providers who reported "excellent" or "good" on the GES at Month 6 and Month 12 are reported here.
Change From Baseline in Body Weight at Month 6 and Month 12 Baseline, Month 6, Month 12 Adjusted LS means and SE were obtained using MMRM model with fixed categorical effects of treatment arm, visit, treatment arm-by-visit interaction, randomization strata of HbA1c target (\<8% / \<7%), SU use (yes/no), GLP-1 RA use (yes/no), as well as baseline weight (as continuous) and baseline weight-by-visit interaction.
Percentage of Participants Reaching Individualized HbA1c Target Without Documented Symptomatic <3.0 mmol/L (<54 mg/dL) and/or Severe Hypoglycemia During the 6-Month Randomized Period Baseline to Month 6 HEDIS criteria for Individualized HbA1c target: \<8% if age \>= 65 years or presence of medical comorbidities, or otherwise \<7%. Severe hypoglycaemia was an event in which the participant required the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Documented symptomatic hypoglycaemia was an event during which typical symptoms of hypoglycaemia were accompanied by a measured plasma glucose concentration of \<54 mg/dL (3.0 mmol/L).
Change From Baseline in Fasting Plasma Glucose (FPG) at Month 6 and Month 12 Baseline, Month 6, Month 12 Change in FPG was calculated by subtracting baseline value from Month 6 and Month 12 values. Adjusted LS means and SE were obtained using MMRM model with fixed categorical effects of treatment arm, randomization strata of HbA1c target (\<8% / \<7%), SU use (yes/no), GLP-1 RA use (yes/no), as well as baseline FPG (as continuous) and baseline FPG-by-visit interaction.
Scores of Total Treatment Satisfaction, Hyperglycemia Perception, and Hypoglycemia Perception From Diabetes Treatment Satisfaction Questionnaire Status Version (DTSQs) at Baseline, Month 6, Month 12 At Baseline, Month 6, Month 12 DTSQs is a validated questionnaire to assess participant's satisfaction with their diabetes treatment. It consists of 8 items, each answered on a Likert scale of 0 to 6. Responses of 6 questions (Items 1, 4, 5, 6, 7 and 8) were summarized to derive total treatment satisfaction score, such that a higher score was indicative of better satisfaction. Total treatment satisfaction score is the sum of items 1, 4-8 scores and ranged from 0 (no satisfaction) to 36 (improvement in treatment satisfaction). Item 2 and Item 3 scores were used for hyperglycemia perception and hypoglycemia perception respectively, where lower scores indicated better health outcome. Perceived frequency of hyperglycemia score (Item 2) and perceived frequency of hypoglycemia score (Item 3) range from 0 (none of the time) to 6 (most of time), where lower scores indicated more satisfaction/better health outcome.
Scores of Total Treatment Satisfaction, Hyperglycemia Perception, and Hypoglycemia Perception From Diabetes Treatment Satisfaction Questionnaire Change Version (DTSQc) at Month 12 At Month 12 DTSQc version evaluates the change in treatment satisfaction at Month 12 as compared to the start of the study . It consists of 8 items, each answered on a Likert scale from -3 to +3. The sum of treatment satisfaction scores (items 1, 4, 5, 6, 7,and 8) ranged from score -18 (deterioration in treatment satisfaction) to +18 (improvement in treatment satisfaction). Perceived frequency of hypoglycemia and perceived frequency of hyperglycemia score ranges from score -3 (fewer problems) to +3 (more problems).
Change From Baseline in Basal Insulin Dose at Month 6 and Month 12 Baseline, Month 6, Month 12 Change in basal insulin dose was calculated by subtracting baseline value from Month 6 and Month 12 values.
Percentage of Participants With at Least One Treatment-Emergent Hypoglycemia Event (Any Time of the Day, Nocturnal) Per Type of Hypoglycaemia During the Month 6 and Month 12 on Treatment Period Up to Month 6 and Month 12 Severe hypoglycaemia was an event in which the participant required the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Documented symptomatic hypoglycaemia was an event during which typical symptoms of hypoglycaemia were accompanied by a measured plasma glucose concentration of \<=70 mg/dL (\<=3.9 mmol/L) or \<54 mg/dL (3.0 mmol/L).
Percentage of Participants With Hospitalizations, Emergency Rooms and Specialty Visits From Baseline to Month 6 and Month 12 From Baseline to Month 6 and Month 12 Percentage of participants with hospitalizations, emergency room visits, and specialty visits during the 6-month and 12-month randomized period were reported. The 12-month randomized period was defined as the time from randomization up to Day 365 or discontinuation date, whichever comes earlier.
Trial Locations
- Locations (427)
Investigational Site Number 840371
🇺🇸Los Angeles, California, United States
Investigational Site Number 840779
🇺🇸Cleveland, Ohio, United States
Investigational Site Number 840348
🇺🇸Pittsburgh, Pennsylvania, United States
Investigational Site Number 840654
🇺🇸Sheffield, Alabama, United States
Investigational Site Number 840634
🇺🇸Sheffield, Alabama, United States
Investigational Site Number 840739
🇺🇸Guntersville, Alabama, United States
Investigational Site Number 840367
🇺🇸Huntsville, Alabama, United States
Investigational Site Number 840528
🇺🇸Little Rock, Arkansas, United States
Investigational Site Number 840024
🇺🇸Escondido, California, United States
Investigational Site Number 840467
🇺🇸Upland, California, United States
Investigational Site Number 840218
🇺🇸Gulf Shores, Alabama, United States
Investigational Site Number 840613
🇺🇸Sheffield, Alabama, United States
Investigational Site Number 840142
🇺🇸Jacksonville, Florida, United States
Investigational Site Number 840449
🇺🇸Bradenton, Florida, United States
Investigational Site Number 840303
🇺🇸Miami Lakes, Florida, United States
Investigational Site Number 840792
🇺🇸Torrance, California, United States
Investigational Site Number 840266
🇺🇸Sherman Oaks, California, United States
Investigational Site Number 840725
🇺🇸Conway, Arkansas, United States
Investigational Site Number 840790
🇺🇸Jonesboro, Arkansas, United States
Investigational Site Number 840156
🇺🇸Santa Ana, California, United States
Investigational Site Number 840699
🇺🇸Little Rock, Arkansas, United States
Investigational Site Number 840329
🇺🇸Littleton, Colorado, United States
Investigational Site Number 840337
🇺🇸Bakersfield, California, United States
Investigational Site Number 840652
🇺🇸Boca Raton, Florida, United States
Investigational Site Number 840472
🇺🇸Whittier, California, United States
Investigational Site Number 840687
🇺🇸Northglenn, Colorado, United States
Investigational Site Number 840115
🇺🇸Torrance, California, United States
Investigational Site Number 840188
🇺🇸Englewood, Colorado, United States
Investigational Site Number 840446
🇺🇸Coral Gables, Florida, United States
Investigational Site Number 840021
🇺🇸Jupiter, Florida, United States
Investigational Site Number 840068
🇺🇸Fort Lauderdale, Florida, United States
Investigational Site Number 840232
🇺🇸Atlanta, Georgia, United States
Investigational Site Number 840081
🇺🇸Cooper City, Florida, United States
Investigational Site Number 840645
🇺🇸Paris, Kentucky, United States
Investigational Site Number 840820
🇺🇸Columbus, Georgia, United States
Investigational Site Number 840592
🇺🇸Covington, Louisiana, United States
Investigational Site Number 840463
🇺🇸Lake Charles, Louisiana, United States
Investigational Site Number 840145
🇺🇸Hialeah, Florida, United States
Investigational Site Number 840035
🇺🇸Fort Lauderdale, Florida, United States
Investigational Site Number 840311
🇺🇸Shreveport, Louisiana, United States
Investigational Site Number 840423
🇺🇸Boston, Massachusetts, United States
Investigational Site Number 840727
🇺🇸Smyrna, Georgia, United States
Investigational Site Number 840801
🇺🇸Ashland, Kentucky, United States
Investigational Site Number 840117
🇺🇸Alpena, Michigan, United States
Investigational Site Number 840302
🇺🇸Bridgeton, Missouri, United States
Investigational Site Number 840444
🇺🇸Macon, Georgia, United States
Investigational Site Number 840199
🇺🇸Port Charlotte, Florida, United States
Investigational Site Number 840129
🇺🇸Blue Ridge, Georgia, United States
Investigational Site Number 840786
🇺🇸New Albany, Indiana, United States
Investigational Site Number 840052
🇺🇸Muncie, Indiana, United States
Investigational Site Number 840226
🇺🇸Morton, Illinois, United States
Investigational Site Number 840150
🇺🇸Flint, Michigan, United States
Investigational Site Number 840534
🇺🇸Baltimore, Maryland, United States
Investigational Site Number 840324
🇺🇸Evansville, Indiana, United States
Investigational Site Number 840754
🇺🇸Benton, Kentucky, United States
Investigational Site Number 840686
🇺🇸Council Bluffs, Iowa, United States
Investigational Site Number 840053
🇺🇸Essexville, Michigan, United States
Investigational Site Number 840258
🇺🇸Stevensville, Michigan, United States
Investigational Site Number 840158
🇺🇸Troy, Michigan, United States
Investigational Site Number 840753
🇺🇸Billings, Montana, United States
Investigational Site Number 840636
🇺🇸Wilmington, North Carolina, United States
Investigational Site Number 840800
🇺🇸Miamisburg, Ohio, United States
Investigational Site Number 840387
🇺🇸Bangor, Maine, United States
Investigational Site Number 840659
🇺🇸Great Neck, New York, United States
Investigational Site Number 840626
🇺🇸New York, New York, United States
Investigational Site Number 840393
🇺🇸Rockville, Maryland, United States
Investigational Site Number 840455
🇺🇸Catonsville, Maryland, United States
Investigational Site Number 840264
🇺🇸Elkhorn, Nebraska, United States
Investigational Site Number 840184
🇺🇸Flint, Michigan, United States
Investigational Site Number 840716
🇺🇸Nesconset, New York, United States
Investigational Site Number 840087
🇺🇸Henderson, Nevada, United States
Investigational Site Number 840603
🇺🇸Butte, Montana, United States
Investigational Site Number 840559
🇺🇸Teaneck, New Jersey, United States
Investigational Site Number 840799
🇺🇸Edison, New Jersey, United States
Investigational Site Number 840688
🇺🇸Mooresville, North Carolina, United States
Investigational Site Number 840789
🇺🇸Merrick, New York, United States
Investigational Site Number 840586
🇺🇸New York, New York, United States
Investigational Site Number 840545
🇺🇸Fargo, North Dakota, United States
Investigational Site Number 840144
🇺🇸Nashua, New Hampshire, United States
Investigational Site Number 840159
🇺🇸Jamaica, New York, United States
Investigational Site Number 840679
🇺🇸Sicklerville, New Jersey, United States
Investigational Site Number 840355
🇺🇸Brooklyn, New York, United States
Investigational Site Number 840060
🇺🇸Neptune, New Jersey, United States
Investigational Site Number 840761
🇺🇸Reno, Nevada, United States
Investigational Site Number 840148
🇺🇸Lake Success, New York, United States
Investigational Site Number 840573
🇺🇸New Bern, North Carolina, United States
Investigational Site Number 840584
🇺🇸Lyndhurst, Ohio, United States
Investigational Site Number 840165
🇺🇸Marion, Ohio, United States
Investigational Site Number 840523
🇺🇸Lansdale, Pennsylvania, United States
Investigational Site Number 840181
🇺🇸Fleetwood, Pennsylvania, United States
Investigational Site Number 840644
🇺🇸Holbrook, New York, United States
Investigational Site Number 840174
🇺🇸Philadelphia, Pennsylvania, United States
Investigational Site Number 840380
🇺🇸Columbus, Ohio, United States
Investigational Site Number 840339
🇺🇸Columbus, Ohio, United States
Investigational Site Number 840063
🇺🇸Columbus, Ohio, United States
Investigational Site Number 840191
🇺🇸Columbus, Ohio, United States
Investigational Site Number 840684
🇺🇸Elyria, Ohio, United States
Investigational Site Number 840103
🇺🇸Bend, Oregon, United States
Investigational Site Number 840776
🇺🇸Greensboro, North Carolina, United States
Investigational Site Number 840743
🇺🇸Greensburg, Pennsylvania, United States
Investigational Site Number 840360
🇺🇸Midwest City, Oklahoma, United States
Investigational Site Number 840560
🇺🇸Tallmadge, Ohio, United States
Investigational Site Number 840067
🇺🇸Philadelphia, Pennsylvania, United States
Investigational Site Number 840277
🇺🇸Philadelphia, Pennsylvania, United States
Investigational Site Number 840561
🇺🇸Philadelphia, Pennsylvania, United States
Investigational Site Number 840663
🇺🇸Findlay, Ohio, United States
Investigational Site Number 840126
🇺🇸Gallipolis, Ohio, United States
Investigational Site Number 840797
🇺🇸Vandalia, Ohio, United States
Investigational Site Number 840192
🇺🇸Wadsworth, Ohio, United States
Investigational Site Number 840262
🇺🇸Edmond, Oklahoma, United States
Investigational Site Number 840759
🇺🇸Simpsonville, South Carolina, United States
Investigational Site Number 840479
🇺🇸Huntingdon Valley, Pennsylvania, United States
Investigational Site Number 840379
🇺🇸Franklin, Ohio, United States
Investigational Site Number 840378
🇺🇸Providence, Rhode Island, United States
Investigational Site Number 840182
🇺🇸Houston, Texas, United States
Investigational Site Number 840043
🇺🇸Greer, South Carolina, United States
Investigational Site Number 840059
🇺🇸Downingtown, Pennsylvania, United States
Investigational Site Number 840032
🇺🇸Penndel, Pennsylvania, United States
Investigational Site Number 840132
🇺🇸Kingsport, Tennessee, United States
Investigational Site Number 124002
🇨🇦Barrie, Canada
Investigational Site Number 840748
🇺🇸Sayre, Pennsylvania, United States
Investigational Site Number 840333
🇺🇸Dallas, Texas, United States
Investigational Site Number 840009
🇺🇸Beaver, Pennsylvania, United States
Investigational Site Number 840712
🇺🇸Indiana, Pennsylvania, United States
Investigational Site Number 840382
🇺🇸Lampasas, Texas, United States
Investigational Site Number 840662
🇺🇸Hampton, Virginia, United States
Investigational Site Number 840011
🇺🇸Dallas, Texas, United States
Investigational Site Number 840013
🇺🇸Dallas, Texas, United States
Investigational Site Number 840403
🇺🇸Irving, Texas, United States
Investigational Site Number 840732
🇺🇸Greenville, South Carolina, United States
Investigational Site Number 840550
🇺🇸Jackson, Tennessee, United States
Investigational Site Number 840308
🇺🇸McAllen, Texas, United States
Investigational Site Number 840260
🇺🇸Humble, Texas, United States
Investigational Site Number 840590
🇺🇸Chesapeake, Virginia, United States
Investigational Site Number 840140
🇺🇸Knoxville, Tennessee, United States
Investigational Site Number 840491
🇺🇸Anderson, South Carolina, United States
Investigational Site Number 840313
🇺🇸Dallas, Texas, United States
Investigational Site Number 840034
🇺🇸Dallas, Texas, United States
Investigational Site Number 840717
🇺🇸Bristol, Tennessee, United States
Investigational Site Number 840327
🇺🇸North Myrtle Beach, South Carolina, United States
Investigational Site Number 840213
🇺🇸Amarillo, Texas, United States
Investigational Site Number 840351
🇺🇸Missouri City, Texas, United States
Investigational Site Number 840628
🇺🇸Summerville, South Carolina, United States
Investigational Site Number 840809
🇺🇸Waxahachie, Texas, United States
Investigational Site Number 840392
🇺🇸Clinton, Utah, United States
Investigational Site Number 840680
🇺🇸Lubbock, Texas, United States
Investigational Site Number 840366
🇺🇸Houston, Texas, United States
Investigational Site Number 840502
🇺🇸Houston, Texas, United States
Investigational Site Number 840306
🇺🇸Houston, Texas, United States
Investigational Site Number 840521
🇺🇸Houston, Texas, United States
Investigational Site Number 840307
🇺🇸Fort Worth, Texas, United States
Investigational Site Number 124001
🇨🇦Brampton, Canada
Investigational Site Number 124013
🇨🇦Concord, Canada
Investigational Site Number 124010
🇨🇦London, Canada
Investigational Site Number 124030
🇨🇦Burlington, Canada
Investigational Site Number 124014
🇨🇦Etobicoke, Canada
Investigational Site Number 840595
🇺🇸Lewisburg, West Virginia, United States
Investigational Site Number 840354
🇺🇸Virginia Beach, Virginia, United States
Investigational Site Number 840658
🇺🇸Charleston, West Virginia, United States
Investigational Site Number 124018
🇨🇦Etobicoke, Canada
Investigational Site Number 124026
🇨🇦Guelph, Canada
Investigational Site Number 840588
🇺🇸Vancouver, Washington, United States
Investigational Site Number 124005
🇨🇦Brampton, Canada
Investigational Site Number 840084
🇺🇸Walla Walla, Washington, United States
Investigational Site Number 124020
🇨🇦Montreal, Canada
Investigational Site Number 124024
🇨🇦Oakville, Canada
Investigational Site Number 124007
🇨🇦Surrey, Canada
Investigational Site Number 124025
🇨🇦Vancouver, Canada
Investigational Site Number 840608
🇺🇸Houston, Texas, United States
Investigational Site Number 840513
🇺🇸Houston, Texas, United States
Investigational Site Number 840323
🇺🇸Houston, Texas, United States
Investigational Site Number 840533
🇺🇸Houston, Texas, United States
Investigational Site Number 840211
🇺🇸Houston, Texas, United States
Investigational Site Number 840002
🇺🇸Miami, Florida, United States
Investigational Site Number 840698
🇺🇸Miami, Florida, United States
Investigational Site Number 840102
🇺🇸Miami, Florida, United States
Investigational Site Number 840209
🇺🇸Miami, Florida, United States
Investigational Site Number 840128
🇺🇸Miami, Florida, United States
Investigational Site Number 840143
🇺🇸Miami, Florida, United States
Investigational Site Number 840349
🇺🇸Miami, Florida, United States
Investigational Site Number 840758
🇺🇸Miami, Florida, United States
Investigational Site Number 840690
🇺🇸Miami, Florida, United States
Investigational Site Number 840664
🇺🇸Las Vegas, Nevada, United States
Investigational Site Number 840108
🇺🇸Las Vegas, Nevada, United States
Investigational Site Number 840656
🇺🇸Las Vegas, Nevada, United States
Investigational Site Number 840638
🇺🇸Las Vegas, Nevada, United States
Investigational Site Number 840750
🇺🇸Las Vegas, Nevada, United States
Investigational Site Number 840815
🇺🇸Las Vegas, Nevada, United States
Investigational Site Number 840162
🇺🇸San Diego, California, United States
Investigational Site Number 840064
🇺🇸Cincinnati, Ohio, United States
Investigational Site Number 840701
🇺🇸Cincinnati, Ohio, United States
Investigational Site Number 840134
🇺🇸Topeka, Kansas, United States
Investigational Site Number 840299
🇺🇸Nashville, Tennessee, United States
Investigational Site Number 840074
🇺🇸San Antonio, Texas, United States
Investigational Site Number 840691
🇺🇸San Antonio, Texas, United States
Investigational Site Number 840018
🇺🇸San Antonio, Texas, United States
Investigational Site Number 840434
🇺🇸San Antonio, Texas, United States
Investigational Site Number 840390
🇺🇸San Antonio, Texas, United States
Investigational Site Number 840289
🇺🇸Detroit, Michigan, United States
Investigational Site Number 840363
🇺🇸Oklahoma City, Oklahoma, United States
Investigational Site Number 840556
🇺🇸Oklahoma City, Oklahoma, United States
Investigational Site Number 840742
🇺🇸Omaha, Nebraska, United States
Investigational Site Number 840731
🇺🇸Birmingham, Alabama, United States
Investigational Site Number 840305
🇺🇸Birmingham, Alabama, United States
Investigational Site Number 840811
🇺🇸Birmingham, Alabama, United States
Investigational Site Number 840170
🇺🇸Denver, Colorado, United States
Investigational Site Number 124017
🇨🇦Calgary, Canada
Investigational Site Number 124008
🇨🇦Hamilton, Canada
Investigational Site Number 124027
🇨🇦Hamilton, Canada
Investigational Site Number 124015
🇨🇦Markham, Canada
Investigational Site Number 124029
🇨🇦Saint-Laurent, Canada
Investigational Site Number 124003
🇨🇦Toronto, Canada
Investigational Site Number 840729
🇺🇸Montgomery, Alabama, United States
Investigational Site Number 840281
🇺🇸Saraland, Alabama, United States
Investigational Site Number 840130
🇺🇸Montgomery, Alabama, United States
Investigational Site Number 840228
🇺🇸Salt Lake City, Utah, United States
Investigational Site Number 840765
🇺🇸West Jordan, Utah, United States
Investigational Site Number 840806
🇺🇸West Jordan, Utah, United States
Investigational Site Number 840810
🇺🇸New Hyde Park, New York, United States
Investigational Site Number 840072
🇺🇸New Hyde Park, New York, United States
Investigational Site Number 840674
🇺🇸New Windsor, New York, United States
Investigational Site Number 840773
🇺🇸Syosset, New York, United States
Investigational Site Number 840047
🇺🇸Yonkers, New York, United States
Investigational Site Number 840089
🇺🇸El Cajon, California, United States
Investigational Site Number 840470
🇺🇸Imperial, California, United States
Investigational Site Number 840020
🇺🇸Fresno, California, United States
Investigational Site Number 840710
🇺🇸Laguna Hills, California, United States
Investigational Site Number 840155
🇺🇸Inglewood, California, United States
Investigational Site Number 840161
🇺🇸Inglewood, California, United States
Investigational Site Number 840194
🇺🇸Laguna Hills, California, United States
Investigational Site Number 840310
🇺🇸Los Angeles, California, United States
Investigational Site Number 840504
🇺🇸Los Angeles, California, United States
Investigational Site Number 840340
🇺🇸Los Angeles, California, United States
Investigational Site Number 840015
🇺🇸Northridge, California, United States
Investigational Site Number 840309
🇺🇸Los Gatos, California, United States
Investigational Site Number 840090
🇺🇸Orange, California, United States
Investigational Site Number 840056
🇺🇸Norwalk, California, United States
Investigational Site Number 840256
🇺🇸North Hollywood, California, United States
Investigational Site Number 840078
🇺🇸Palm Springs, California, United States
Investigational Site Number 840791
🇺🇸Palmdale, California, United States
Investigational Site Number 840216
🇺🇸Paramount, California, United States
Investigational Site Number 840383
🇺🇸San Dimas, California, United States
Investigational Site Number 840028
🇺🇸San Diego, California, United States
Investigational Site Number 840627
🇺🇸San Jose, California, United States
Investigational Site Number 840120
🇺🇸San Ramon, California, United States
Investigational Site Number 840643
🇺🇸Aventura, Florida, United States
Investigational Site Number 840141
🇺🇸Fleming Island, Florida, United States
Investigational Site Number 840728
🇺🇸Littleton, Colorado, United States
Investigational Site Number 840083
🇺🇸Doral, Florida, United States
Investigational Site Number 840407
🇺🇸Cutler Bay, Florida, United States
Investigational Site Number 840362
🇺🇸Margate, Florida, United States
Investigational Site Number 840197
🇺🇸Miami, Florida, United States
Investigational Site Number 840080
🇺🇸Panama City, Florida, United States
Investigational Site Number 840118
🇺🇸Palm Harbor, Florida, United States
Investigational Site Number 840372
🇺🇸Plantation, Florida, United States
Investigational Site Number 840261
🇺🇸Atlanta, Georgia, United States
Investigational Site Number 840767
🇺🇸Decatur, Georgia, United States
Investigational Site Number 840110
🇺🇸Lawrenceville, Georgia, United States
Investigational Site Number 840003
🇺🇸Marietta, Georgia, United States
Investigational Site Number 840632
🇺🇸Sandersville, Georgia, United States
Investigational Site Number 840591
🇺🇸Savannah, Georgia, United States
Investigational Site Number 840520
🇺🇸Snellville, Georgia, United States
Investigational Site Number 840163
🇺🇸Statesboro, Georgia, United States
Investigational Site Number 840764
🇺🇸Boise, Idaho, United States
Investigational Site Number 840297
🇺🇸Stockbridge, Georgia, United States
Investigational Site Number 840715
🇺🇸Thomson, Georgia, United States
Investigational Site Number 840005
🇺🇸Chicago, Illinois, United States
Investigational Site Number 840399
🇺🇸Chicago, Illinois, United States
Investigational Site Number 840402
🇺🇸Joliet, Illinois, United States
Investigational Site Number 840301
🇺🇸Elgin, Illinois, United States
Investigational Site Number 840125
🇺🇸Avon, Indiana, United States
Investigational Site Number 840344
🇺🇸Brownsburg, Indiana, United States
Investigational Site Number 840164
🇺🇸Evansville, Indiana, United States
Investigational Site Number 840536
🇺🇸Greenfield, Indiana, United States
Investigational Site Number 840022
🇺🇸Franklin, Indiana, United States
Investigational Site Number 840582
🇺🇸Indianapolis, Indiana, United States
Investigational Site Number 840694
🇺🇸Michigan City, Indiana, United States
Investigational Site Number 840524
🇺🇸Troy, Michigan, United States
Investigational Site Number 840033
🇺🇸Olive Branch, Mississippi, United States
Investigational Site Number 840041
🇺🇸Jefferson City, Missouri, United States
Investigational Site Number 840711
🇺🇸Saint Louis, Missouri, United States
Investigational Site Number 840772
🇺🇸Amityville, New York, United States
Investigational Site Number 840136
🇺🇸Brooklyn, New York, United States
Investigational Site Number 840714
🇺🇸Burlington, North Carolina, United States
Investigational Site Number 840697
🇺🇸Shelby, North Carolina, United States
Investigational Site Number 840077
🇺🇸Canal Fulton, Ohio, United States
Investigational Site Number 840771
🇺🇸Kettering, Ohio, United States
Investigational Site Number 840751
🇺🇸Wooster, Ohio, United States
Investigational Site Number 840405
🇺🇸Dallas, Texas, United States
Investigational Site Number 840330
🇺🇸El Paso, Texas, United States
Investigational Site Number 840377
🇺🇸Houston, Texas, United States
Investigational Site Number 840171
🇺🇸Jackson, Tennessee, United States
Investigational Site Number 840625
🇺🇸Memphis, Tennessee, United States
Investigational Site Number 840135
🇺🇸San Antonio, Texas, United States
Investigational Site Number 840639
🇺🇸Kissimmee, Florida, United States
Investigational Site Number 840777
🇺🇸Lake Clarke Shores, Florida, United States
Investigational Site Number 840014
🇺🇸Miami, Florida, United States
Investigational Site Number 840415
🇺🇸Miami, Florida, United States
Investigational Site Number 840508
🇺🇸Ocala, Florida, United States
Investigational Site Number 840414
🇺🇸Miami, Florida, United States
Investigational Site Number 840092
🇺🇸Ocoee, Florida, United States
Investigational Site Number 840538
🇺🇸Winter Haven, Florida, United States
Investigational Site Number 840173
🇺🇸Phoenix, Arizona, United States
Investigational Site Number 840555
🇺🇸Phoenix, Arizona, United States
Investigational Site Number 840204
🇺🇸Lancaster, California, United States
Investigational Site Number 840612
🇺🇸Tulare, California, United States
Investigational Site Number 840413
🇺🇸Pomona, California, United States
Investigational Site Number 840244
🇺🇸Port Hueneme, California, United States
Investigational Site Number 840091
🇺🇸Sylmar, California, United States
Investigational Site Number 840812
🇺🇸Decatur, Georgia, United States
Investigational Site Number 840342
🇺🇸Covington, Kentucky, United States
Investigational Site Number 840478
🇺🇸Owensboro, Kentucky, United States
Investigational Site Number 840819
🇺🇸Owensboro, Kentucky, United States
Investigational Site Number 840744
🇺🇸Covington, Louisiana, United States
Investigational Site Number 840622
🇺🇸Monroe, Louisiana, United States
Investigational Site Number 840673
🇺🇸Zachary, Louisiana, United States
Investigational Site Number 840109
🇺🇸Murrells Inlet, South Carolina, United States
Investigational Site Number 840466
🇺🇸West Des Moines, Iowa, United States
Investigational Site Number 840294
🇺🇸Henderson, Nevada, United States
Investigational Site Number 840736
🇺🇸Danville, Virginia, United States
Investigational Site Number 840795
🇺🇸Lynchburg, Virginia, United States
Investigational Site Number 840088
🇺🇸Norfolk, Virginia, United States
Investigational Site Number 840247
🇺🇸North Chesterfield, Virginia, United States
Investigational Site Number 840704
🇺🇸Winchester, Virginia, United States
Investigational Site Number 840763
🇺🇸Greensboro, North Carolina, United States
Investigational Site Number 840096
🇺🇸Salisbury, North Carolina, United States
Investigational Site Number 840747
🇺🇸Mooresville, North Carolina, United States
Investigational Site Number 840361
🇺🇸Greenville, North Carolina, United States
Investigational Site Number 840195
🇺🇸Wilson, North Carolina, United States
Investigational Site Number 840805
🇺🇸Sun City, Arizona, United States
Investigational Site Number 840079
🇺🇸Searcy, Arkansas, United States
Investigational Site Number 840012
🇺🇸Miami, Florida, United States
Investigational Site Number 840596
🇺🇸Denver, Colorado, United States
Investigational Site Number 840185
🇺🇸Vista, California, United States
Investigational Site Number 840208
🇺🇸Thousand Oaks, California, United States
Investigational Site Number 840352
🇺🇸Jacksonville, Florida, United States
Investigational Site Number 840027
🇺🇸Coral Gables, Florida, United States
Investigational Site Number 840640
🇺🇸Kissimmee, Florida, United States
Investigational Site Number 840221
🇺🇸Miami Lakes, Florida, United States
Investigational Site Number 840700
🇺🇸Dunwoody, Georgia, United States
Investigational Site Number 840648
🇺🇸East Point, Georgia, United States
Investigational Site Number 840616
🇺🇸Savannah, Georgia, United States
Investigational Site Number 840400
🇺🇸Blackfoot, Idaho, United States
Investigational Site Number 840713
🇺🇸Elizabethtown, Kentucky, United States
Investigational Site Number 840619
🇺🇸Slidell, Louisiana, United States
Investigational Site Number 840681
🇺🇸Hopkinsville, Kentucky, United States
Investigational Site Number 840576
🇺🇸Owensboro, Kentucky, United States
Investigational Site Number 840675
🇺🇸Marrero, Louisiana, United States
Investigational Site Number 840007
🇺🇸Evansville, Indiana, United States
Investigational Site Number 840532
🇺🇸Crowley, Louisiana, United States
Investigational Site Number 840760
🇺🇸Hammond, Louisiana, United States
Investigational Site Number 840147
🇺🇸Natchitoches, Louisiana, United States
Investigational Site Number 840236
🇺🇸Kalamazoo, Michigan, United States
Investigational Site Number 840689
🇺🇸Portland, Maine, United States
Investigational Site Number 840412
🇺🇸Las Vegas, Nevada, United States
Investigational Site Number 840693
🇺🇸Chesterfield, Missouri, United States
Investigational Site Number 840214
🇺🇸Asheville, North Carolina, United States
Investigational Site Number 840587
🇺🇸Smithtown, New York, United States
Investigational Site Number 840296
🇺🇸Morganton, North Carolina, United States
Investigational Site Number 840481
🇺🇸Albany, New York, United States
Investigational Site Number 840746
🇺🇸Babylon, New York, United States
Investigational Site Number 840253
🇺🇸Laurelton, New York, United States
Investigational Site Number 840705
🇺🇸High Point, North Carolina, United States
Investigational Site Number 840734
🇺🇸Forest Hills, New York, United States
Investigational Site Number 840577
🇺🇸Staten Island, New York, United States
Investigational Site Number 840237
🇺🇸Burlington, North Carolina, United States
Investigational Site Number 840752
🇺🇸Columbus, Ohio, United States
Investigational Site Number 840456
🇺🇸Charlotte, North Carolina, United States
Investigational Site Number 840611
🇺🇸Greensboro, North Carolina, United States
Investigational Site Number 840755
🇺🇸Lexington, North Carolina, United States
Investigational Site Number 840187
🇺🇸Smithfield, Pennsylvania, United States
Investigational Site Number 840515
🇺🇸Toledo, Ohio, United States
Investigational Site Number 840738
🇺🇸Canton, Ohio, United States
Investigational Site Number 840549
🇺🇸Mesquite, Texas, United States
Investigational Site Number 840389
🇺🇸Willoughby Hills, Ohio, United States
Investigational Site Number 840287
🇺🇸Uniontown, Pennsylvania, United States
Investigational Site Number 840439
🇺🇸Plano, Texas, United States
Investigational Site Number 840292
🇺🇸Altoona, Pennsylvania, United States
Investigational Site Number 840766
🇺🇸Levittown, Pennsylvania, United States
Investigational Site Number 840341
🇺🇸Uniontown, Pennsylvania, United States
Investigational Site Number 840669
🇺🇸Pottstown, Pennsylvania, United States
Investigational Site Number 840373
🇺🇸Palestine, Texas, United States
Investigational Site Number 840160
🇺🇸Chattanooga, Tennessee, United States
Investigational Site Number 840157
🇺🇸Corpus Christi, Texas, United States
Investigational Site Number 840137
🇺🇸Houston, Texas, United States
Investigational Site Number 840794
🇺🇸Franklin, Tennessee, United States
Investigational Site Number 840381
🇺🇸New Tazewell, Tennessee, United States
Investigational Site Number 840365
🇺🇸Pharr, Texas, United States
Investigational Site Number 840097
🇺🇸Sugar Land, Texas, United States
Investigational Site Number 840707
🇺🇸Port Arthur, Texas, United States
Investigational Site Number 840692
🇺🇸Richmond, Texas, United States
Investigational Site Number 840431
🇺🇸San Antonio, Texas, United States
Investigational Site Number 840207
🇺🇸Schertz, Texas, United States
Investigational Site Number 840176
🇺🇸San Antonio, Texas, United States
Investigational Site Number 840530
🇺🇸Sugar Land, Texas, United States
Investigational Site Number 840615
🇺🇸Sealy, Texas, United States
Investigational Site Number 840460
🇺🇸Sugar Land, Texas, United States
Investigational Site Number 840008
🇺🇸Waco, Texas, United States
Investigational Site Number 840651
🇺🇸Webster, Texas, United States
Investigational Site Number 840593
🇺🇸Waco, Texas, United States
Investigational Site Number 840189
🇺🇸Saint George, Utah, United States
Investigational Site Number 840580
🇺🇸Chatham, Virginia, United States
Investigational Site Number 840706
🇺🇸Danville, Virginia, United States
Investigational Site Number 840788
🇺🇸Danville, Virginia, United States
Investigational Site Number 840620
🇺🇸Newport News, Virginia, United States
Investigational Site Number 840076
🇺🇸Salem, Virginia, United States
Investigational Site Number 840730
🇺🇸Pennington Gap, Virginia, United States
Investigational Site Number 840575
🇺🇸Fredericksburg, Virginia, United States
Investigational Site Number 840605
🇺🇸Martinsville, Virginia, United States
Investigational Site Number 124016
🇨🇦Newmarket, Canada
Investigational Site Number 840709
🇺🇸Everett, Washington, United States
Investigational Site Number 840238
🇺🇸Federal Way, Washington, United States
Investigational Site Number 840133
🇺🇸Metairie, Louisiana, United States
Investigational Site Number 840210
🇺🇸Southfield, Michigan, United States
Investigational Site Number 840312
🇺🇸Concord, North Carolina, United States
Investigational Site Number 840315
🇺🇸Winston-Salem, North Carolina, United States
Investigational Site Number 840411
🇺🇸Aurora, Colorado, United States
Investigational Site Number 840578
🇺🇸Louisville, Kentucky, United States
Investigational Site Number 840514
🇺🇸Sugar Land, Texas, United States
Investigational Site Number 840175
🇺🇸Des Moines, Iowa, United States
Investigational Site Number 840609
🇺🇸New Orleans, Louisiana, United States
Investigational Site Number 840179
🇺🇸Richmond, Virginia, United States
Investigational Site Number 840318
🇺🇸Peoria, Illinois, United States
Investigational Site Number 840044
🇺🇸North Massapequa, New York, United States
Investigational Site Number 840257
🇺🇸Lancaster, Ohio, United States
Investigational Site Number 840741
🇺🇸Versailles, Kentucky, United States
Investigational Site Number 840167
🇺🇸Linden, New Jersey, United States